Ukraine Notifies WTO of Draft Law Establishing a New Regulatory Framework for Biocidal Products
Reference source : WTO
On 14 September 2026, the World Trade Organization (WTO) circulated Ukraine’s revised notification of its draft Law “On Biocidal Products”. This proposal aims to establish a comprehensive regulatory framework for the approval of active substances, and the registration and placing on the market of biocidal products and treated articles, as well as their safe you. It would also define the responsibilities of businesses, competent authorities and other stakeholders involved in the management of biocidal products.
This framework is an important development in Ukraine’s chemical product regulatory landscape and introduces an EU-aligned system based on Regulation (EU) No 528/2012 on biocidal products. It was developed by the Ministry of Health of Ukraine with the aim of harmonising Ukrainian legislation with the European requirements, while ensuring a high level of protection for human health, animal health and the environment.
Scope and Market Relevance
The draft Law applies to biocidal products, active substances and treated articles placed on the Ukrainian market.
Biocidal products are defined as substances or mixtures intended to destroy, deter, neutralise, prevent the action of harmful organisms or otherwise control them by means other than physical or mechanical action.
The proposed framework covers a wide range of biocidal product categories, including:
- disinfectants;
- preservatives;
- pest control products;
- other biocidal products.
The classification system comprises four main groups and 22 product types, covering applications such as human hygiene products, surface disinfectants, veterinary hygiene products, disinfectants for food and feed areas, preservatives for various materials, insecticides, repellents and attractants, and anti-fouling products.
The proposed requirements are particularly relevant for manufacturers, importers, distributors and companies that place biocidal products or treated articles on the Ukrainian market.
Key Regulatory Measures Proposed
1. Approval of Active Substances
The draft Law establishes procedures for the approval, renewal and review of the approval of active substances used in biocidal products.
An authorised entity will be responsible for conducting scientific expert assessments of active substances and preparing conclusions regarding their approval or possible use in registered biocidal products. The approval process will include an evaluation of safety, effectiveness and conditions of use, including product type, application area and risk management measures.
This approach reflects the principles established under Regulation (EU) No 528/2012, in which active substance approval is a key element of the biocidal product authorization process.
2. State Registration of Biocidal Products
Under the proposed framework, biocidal products may only be placed on the Ukrainian market and used after state registration.
The registration process will apply to individual biocidal products or product families and will require submission of relevant documentation, including product dossiers, safety information, composition details, manufacturer information, intended uses and risk management measures.
The competent authority will assess the submitted information before granting registration.
3. Establishment of the State Register of Biocidal Products
The draft Law provides for the creation of the State Register of Biocidal Products, which will contain information on registered biocidal products and product families. This new register will be created through modernization of the existing State Register of Disinfectants, and it is expected to become operational on 1 January 2030.
Existing registrations of disinfectants that are valid when the Law enters into force will remain valid until their expiry.
4. Requirements for Treated Articles
The proposed legislation also introduces requirements for treated articles, meaning substances, mixtures or articles that have been treated with or intentionally incorporate biocidal products. Treated articles may only be placed on the market if the relevant active substances are approved for the applicable product type and conditions of use.
Where required, treated articles must include appropriate labelling information regarding the biocidal treatment and the active substances used.
5. Classification, Labelling and Safety Information
The draft Law establishes requirements for the classification, labelling and packaging of biocidal products.
Labelling requirements include information on:
- active substances and their concentrations;
- registration number;
- registrant details;
- product type and approved uses;
- instructions for safe use;
- safety precautions;
- disposal instructions.
Safety data sheets for active substances and biocidal products must comply with Ukrainian chemical safety legislation, including the applicable requirements under the Ukrainian REACH framework.
Business Impact and Recommended Actions
Companies placing biocidal products on the Ukrainian market should monitor the legislative process and evaluate the potential impact on their products.
Businesses should consider:
- identifying products that may fall within the scope of the future biocidal regulation;
- reviewing active substances used in their products;
- checking existing registrations of disinfectants and other biocidal products;
- assessing documentation readiness, including product dossiers and safety information;
- reviewing labelling and packaging requirements;
- monitoring future procedures for registration and approval of active substances.
Early assessment will help companies prepare for the transition to the new regulatory framework before its implementation date.
Legislative Context
The draft Law is linked to Ukraine’s broader chemical safety and product compliance framework, including:
- Law of Ukraine “On Ensuring Chemical Safety and Management of Chemical Products”;
- Law of Ukraine “On Public Health System”;
- Law of Ukraine “On Veterinary Medicine and Animal Welfare”;
- Law of Ukraine “On State Control over Compliance with Legislation on Food, Feed, Animal By-products, Animal Health and Welfare”;
- Ukrainian legislation on technical regulations and conformity assessment.
This initiative has been developed as part of Ukraine’s approximation of national legislation to EU acquis requirements. The explanatory note confirms that the draft Law is intended to implement Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products.
WTO Notification and International Alignment
The revised WTO notification reflects Ukraine’s intention to introduce a structured regulatory framework for biocidal products that is aligned with the EU system.
The draft Law introduces procedures covering active substance approval, biocidal product registration, treated article requirements, classification, labelling and risk assessment procedures.
The proposed framework represents a significant step toward establishing a predictable regulatory system for biocidal products in Ukraine and supporting further integration with EU chemical safety approaches.
Transition Period and Implementation Timeline
The draft Law establishes a transition period before the new regulatory framework becomes fully applicable.
According to the proposed provisions:
- the Law will enter into force on the day after its official publication;
- the Law will be enacted from 1 January 2030;
- the State Register of Biocidal Products should be established by 1 January 2030 through modernization of the existing disinfectant register.
The transition period is intended to provide authorities and economic operators with sufficient time to establish the necessary procedures, systems and documentation required for the implementation of the framework.
Comment Period
The draft Law was notified under the WTO notification procedure, providing stakeholders with an opportunity to submit comments. The deadline for comments is 30 days from the date of circulation of the notification.
Comments should be submitted through the Secretariat of the Cabinet of Ministers of Ukraine, Department of International Trade Policy, which acts as the designated authority for handling comments.